Four reasons to use digital health in your clinical trials

In the first of our digital health series we will outline what the term means, and the opportunities offered, within the context of clinical trials in psychiatry.

Present day neuropsychiatric assessments often heavily rely on the patient’s own subjective insight and past-reflection of symptoms, which can potentially lead to an unreliable measure of the patient’s current mental health status (1).

The issues with relying on patient reported measures have been a major diagnostic concern for decades (2). Furthermore, when these same neuropsychiatric techniques are applied within a clinical trial environment, the lack of objective behavioural assessments can result in a reduced sensitivity for detecting the effects of pharmacological interventions (3).

But can digital health overcome these barriers to clinical trial success and improve patient outcomes?

What is digital health?

We are currently experiencing a defining moment in clinical research that is marked by the synergy between the two major fields of life science and digital technology, creating a new field of healthcare termed digital health.

The term digital health refers to the use of digital platforms, such as mobile phones and wearable technology, to bring healthcare directly to the patient and provide medical treatment that focuses on the personalized needs of the individual.

What is the regulatory perspective on digital health?

Earlier this year, the FDA Commissioner Scott Gottlieb, issued a statement on how the administration would be transforming their approach to digital health so the regulatory approval process could match the pace of this rapidly developing field (4).

“We’ll work to ensure our regulatory approach reflects the novel nature of these products and encourages and supports their innovation. We must recognize the potential of digital health as a new tool to improve the safety and effectiveness of drug delivery.”

Scott Gottlieb, FDA Commissioner

The FDA are streamlining the regulatory process in order to speed up the transition from developing digital health solutions to benefiting patients in the real-world (4).

What are the four key benefits of measuring cognition remotely with digital health tech?

In this series, we will highlight the primary advantages currently offered by digital health platforms. Specifically, the use of remote digital platforms, such as smart phones and wearables, for high-frequency cognitive assessments in clinical populations to enhance the sensitivity for detecting the effects of pharmacological interventions.